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| Statement |
|---|
| I left that call feeling that the FDA has bought in and the patients did a really good job of making the case |
| We believe that based on the data from our IPF cough trial, which showed a strong drug effect across all baseline cough counts and the drug central and peripheral mechanism of action that Haduvio has the potential to work in patients broadly across varying cost frequencies |
| There's a lot of good learnings to be -- which are to our advantage |
| We believe Haduvio's central and peripheral mechanism has the potential to work in more patients and potentially have a stronger effect across a broader range of baseline cough counts than peripheral-only mechanisms like the P2X3 inhibitors |
| We see an exciting road ahead for Trevi and look forward to focusing on execution of our clinical trials to get to data in these important indications beginning in the second half of this year |
| Hopefully, we're successful in Phase 2a and RIVER and we're expanding into the larger studies |
| We are motivated by the potential to offer an effective treatment to patients with these serious conditions and chronic costs |
| Our cash runway guidance that we will have cash, cash equivalents and marketable securities into 2026 remains unchanged, and we believe is enough to fund all of the trials Jennifer just discussed and gives us good cash runway after the last readout |
| It's important for us to get a good feel for dose response and that analysis allows us to do that |
| So we always thought it would work and we thought our drug would likely work better |
| So we think that will be a differentiator really protecting us and what happened to that Merck program, as you said, Jennifer |
| Thank you for taking our questions and congratulations on the nice year end quarter |
| We believe we've seen a very clinically relevant effect, as we've described in the Phase 2a study |
| We take a very disciplined approach to cash management and as a result, while R&D expenses increased as we are starting up four clinical trials |
| So -- but it makes our job easier for sure |
| This study is moving along nicely, and we have passed the 50% enrollment mark |
| I think effect side, what we hope will be a differentiating factor for our program is the effect side |
| We think the opioid pathway works |
| Jennifer Good Thank you |
| Jennifer Good Thank you |
| Good afternoon |
| Leland Gershell Good afternoon and thanks for taking our questions |
| But we also believe that the synergistic effect of working at both kappa and mu (ph) of our drug is important |
| Thank you so much |
| Thanks |
| Thank you |
| Appreciate it and thank you for taking our questions |
| I think we'll also let people know when we hit the 50% enrollment mark so that investors and analysts will know whether we're on sort of the front end of enrollment or the back end of enrollment and we would announce last patient in, that's a pretty big milestone |
| Statement |
|---|
| The constant lung injury micro tears and potential inflammation caused by persistent coughing may lead to worse health outcomes for patients such as increased respiratory hospitalizations, mortality or need for transplant |
| Everything else has failed or been too little |
| Recall that parenteral nalbuphine is unscheduled by the DEA |
| With multiple drug failures in the space and a lack of any approved therapies for RCC in the U.S., there continues to be a significant unmet and urgent need for new potential treatments |
| Think fundamentally, the Merck drug just didn't have good enough efficacy to clear the hurdles and got hung up in the primary endpoint didn't correlate with the pros, etc |
| I think, Leland, our takeaway was -- it wasn't surprising it worked |
| I think the other challenge morphine has just practically is because of the respiratory depression, they are dose limited |
| For the fourth quarter of 2023, we reported a net loss of $7.8 million compared to a net loss of $5.5 million for the same quarter in 2022 |
| Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of the company's most recent quarterly report on Form 10-K, which the company filed with the SEC this afternoon |
| That made a huge impact on me |
| IPF is a serious end-of-life disease |
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